MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Urinary Retention (2119); Malaise (2359); Ambulation Difficulties (2544); Constipation (3274)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Product id: 8780, serial/lot #: (b)(4), ubd: 16-jan-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient representative (friend/family member of the patient) regarding a patient who was receiving a morphine of an unknown concentration at an unknown dose rate via an implantable pump for spinal pain.It was reported that the patient previously had a catheter revision performed on (b)(6) 2020 because their previous catheter had a kink in it, and it took the physician 4 hours to do the revision.Refer also the mfr report # 3004209178-2020-04396 regarding a prior event.It was further reported that since the revision, the patient had been sick and has had weakness in their legs and couldn't walk very well.The patient had also been in the hospital three times since then.The patient had a pump refill in (b)(6) 2020 and two days later they were in the hospital with worse leg weakness.It was noted that the physician told them that this incident was not related to the fill.The patient¿s left leg was weak, and their right leg had no strength.The patient could not pick up his leg.They had to use a hoyer lift to lift the patient as the patient had no use of their legs.It was further noted that the patient also had no inkling that his bowels were moving and the patient had to have a catheter because he could not urinate.The patient had not gotten the relief that they had prior to the revision.The reporter was questing if the pump or catheter could be causing the symptoms.Both the reporter and the patient wanted the pump to be removed and they were looking for a physician to remove the pump.No further patient complications have been reported as a result of this event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10971878
• MDR Text Key: 220644399
• Report Number: 3004209178-2020-21437
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR